Company Category: CMO

Royalmount Laboratories

Royalmount Labs now employs over 45 scientific, technical and support staff, and occupies 8000 sq ft of purpose built laboratory and office space. We have the latest state-of-the-art instrumentation including 13 LC-MS/MSs, 2 multimode spectrophotometer plate readers, a Luminex and 2 robotic liquid handling systems. As a partner of choice for many pharma, biotech and virtual companies, we have a very high rate of repeat business, and this is a testament to our three core principles that we consistently deliver on to our clientele – Scientific Excellence; Customer Service; On-time Delivery. With our unparalleled expertise and customized solutions, we can help you elevate your drug development process to the next level. Whether you need bioanalysis or pharmacokinetic analysis, we have the right team and the right tools. Don’t settle for less, choose Royalmount Laboratories as your partner for your drug development programs.

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Ronawk, Inc.

Ronawk’s Bio-Blocks™ platform is a proprietary 3D bioprinted hydrogel system designed to replicate physiologic microenvironments with exceptional fidelity. It supports the growth and organization of over 80 cell types including primary cells, explants, and co-cultures, enabling tissue-mimetic architecture. Ronawk is advancing a pipeline that includes wound healing, regenerative medicine applications, and immune and stem cell expansion.

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Rise BioServices

Rise BioServices is at the forefront of microbiome science and, with our technology edge, offers better solutions for clean space cGMP and non-GMP manufacturing of novel bacterial- and microbiome-based medicines and products. Utilizing our scientific and regulatory expertise in Live Biotherapeutic Products (LBPs), consumer health probiotics, plasmids, and other cutting-edge bacterial-based therapies, we support emerging and established companies in all aspects of product development and manufacturing. Come chat with us to discuss how we can help you develop your product. | Rise BioServices is a dedicated division of Rise Therapeutics, providing specialized support for external clients and partners in synthetic biology and GMP manufacturing for food and pharma clinical studies. With our state-of-the-art facilities, advanced analytical capabilities, and expertise in drug development, we offer end-to-end solutions to accelerate product development, manufacturing, and clinical translation.

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Richter BioLogics GmbH

Richter BioLogics stands at the forefront of Germany’s contract development and manufacturing sphere, with a specialized focus on products derived from bacteria and yeasts. Our three facilities boast capacities of 2 x 1,500L and 2 x 300L, facilitating the production of plasmid DNA, antibodies, including VHH/nanobodies, proteins, and vaccines. With over 35 years of proven success, our highly skilled teams are dedicated to supporting clients through every stage of production. We offer robust process development, supply products for clinical trials, oversee commercial production, conduct in-house quality control testing, and provide QP release. Our commitment to excellence is reflected in our adherence to the highest pharmaceutical quality standards, as verified by major regulatory bodies such as EMA, FDA, ANVISA, PMDA, and MFDS, alongside numerous customer audits. At Richter BioLogics, we pride ourselves on delivering reliable solutions with precision and expertise, ensuring our partners achieve their clinical and commercial goals with confidence. | Richter BioLogics stands at the forefront of contract development and manufacturing (CDMO) sphere, with a specialized focus on products derived from bacteria and yeasts. Our three facilities boast capacities of 2 x 1,500L and 2 x 300L, facilitating the production of antibodies, including VHH/Nanobodies, proteins, vaccines and plasmid DNA. With over 35 years of proven success, our highly skilled teams are dedicated to supporting clients through every stage of production. We offer robust process development, supply products for clinical trials, commercial production, conduct in-house quality control testing, and provide QP release. Our commitment to excellence is reflected in our adherence to the highest pharmaceutical quality standards, as verified by major regulatory bodies such as EMA, FDA, ANVISA, PMDA, and MFDS, alongside numerous customer audits. At Richter BioLogics, we pride ourselves on delivering reliable solutions with precision and expertise, ensuring our partners achieve their clinical and commercial goals with confidence and in time.

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Resilience

Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines (biologics, vaccines, nucleic acid, cell therapy, and gene therapy modalities). Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives and protect biopharmaceutical supply chains against future disruptions. For more information, visit https://resilience.com/ and follow us on social media: @IncResilience on Twitter and Resilience on LinkedIn. | Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines. Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at-scale. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives and protect biopharmaceutical supply chains against future disruptions. | Resilience is a technology-focused biomanufacturing company dedicated to broadening access to complex medicines (biologics, vaccines, nucleic acid, cell/ gene therapy modalities and drug product). Founded in 2020, the company is building a sustainable network of high-tech, end-to-end manufacturing solutions to ensure the treatments of today and tomorrow can be made quickly, safely, and at scale. By continuously advancing the science of biopharmaceutical manufacturing and development, Resilience seeks to free its partners to focus on the discoveries that improve patients’ lives and protect biopharmaceutical supply chains against future disruptions. For more information, visit https://resilience.com/ and follow us on social media: @IncResilience on Twitter and Resilience on LinkedIn.

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Repligen

Repligen, a global life sciences company, develops and commercializes innovative bioprocessing technologies that increase efficiencies and flexibility in biotherapeutic manufacturing. As leaders in filtration, chromatography systems, process analytics and fluid management, we are committed to inspiring advances in bioprocessing. We are a trusted partner in the production of monoclonal antibodies, recombinant proteins, vaccines as well as cell and gene therapies. Named one of the fastest growing biotech companies in the USA, the majority of our 18 manufacturing sites are located in the United States (California, Massachusetts, New Jersey, New Hampshire, New York and Texas). Outside the United States, we have manufacturing sites in Estonia, France, Germany, Ireland, the Netherlands, and Sweden. | Repligen, a global, bioprocessing-focused life sciences company, provides innovative solutions for the advancement of biotherapeutic manufacturing. Experts in filtration, chromatography systems, process analytics, fluid management, and proteins, Repligen is a trusted partner serving the development and manufacture of a wide range of biologics, including cell and gene therapies, mRNA, monoclonal antibodies (mAbs), antibody–drug conjugates (ADCs), bispecific antibodies, and fusion proteins. Headquartered in Waltham, Massachusetts, USA, Repligen operates across 22 sites, including locations in the United States, Europe, and the Asia-Pacific region. | Inspiring advances in bioprocessing, Repligen is a trusted partner in process intensification, pre-packed chromatography and single-use filtration. Focused on cost and process efficiencies, our people and our technologies help meet critical bioproduction demands worldwide. As the recognized global leader in Protein A manufacturing, Repligen’s Protein A affinity ligands are routinely used to purify most of the world’s monoclonal antibodies.

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Rentschler Biopharma SE

Rentschler Biopharma is a leading contract development and manufacturing organization offering bioprocess development and cGMP manufacturing of biopharmaceuticals and related consulting activities, including project management and regulatory support. Rentschler Biopharma is a family-owned company with about 1,200 employees, headquartered in Laupheim, Germany, with a second site in Milford, USA, and an affiliate dedicated to cell and gene therapies in Stevenage, UK. | Rentschler Biopharma is a leading contract development and manufacturing organization (CDMO), offering process development and cGMP manufacturing of biopharmaceuticals, including adeno-associated virus (AAV) gene therapies, as well as related consulting activities, project management and regulatory support. Rentschler Biopharma is a family-owned company with about 1,200 employees, headquartered in Laupheim, Germany, with a second site in Milford, USA, and an affiliate dedicated to cell and gene therapies in Stevenage, UK. | Rentschler Biopharma is a global leading contract development and manufacturing organization (CDMO) focused exclusively on client projects. The company offers process development and manufacturing of biopharmaceuticals, as well as related consulting activities, project management and regulatory support. Rentschler Biopharma’s high quality is proven by its long-standing experience and excellence as a solution partner for its clients. A high-level quality management system, a well-established operational excellence philosophy ensure product quality and productivity at each development and manufacturing step. Rentschler Biopharma is a family-owned company with about 1,400 employees, headquartered in Laupheim, Germany, with operations in Milford, MA, USA. In 2024, the company joined the United Nations Global Compact, emphasizing Rentschler Biopharma’s focus on sustainability. Rentschler Biopharma brings 50-years of biopharmaceutical CDMO experience in the development and cGMP manufacturing of advanced antibodies and complex proteins, monoclonal antibodies, fusion proteins, recombinant enzymes, as well as advanced therapies. We have leveraged our proven experience top serve more than 170 clients worldwide in compliance with international standards (EMA/FDA). At Rentschler Biopharma, “reliability you can trust” is more than a promise – It’s our commitment. We take pride in our contribution to nearly 25% of FDA-approved biopharmaceuticals in 2023. Working collaboratively with our clients, Rentschler Biopharma provides customized solutions with optimized work packages for each development stage. State-of-the-art cGMP facilities and cell culture processes allow manufacturing for both clinical studies and commercial supply. Ongoing monitoring of the international regulatory landscape and in-depth understanding of the necessary regulatory documentation (CMC) ensures that each project is properly documented in accordance with regulatory requirements. Bioprocess development – Fast and efficient supply for multiple candidate screening – Robust and scalable CHO cell lines for cGMP manufacturing – Efficient cell culture and purification processes for any protein format – Well-established analytical methods – Advanced formulation development cGMP biomanufacturing – Multiple stainless steel bioreactor lines, including a twin system with 2x 3,000 L, flexible single-use bioreactor lines up to 2,000 L – New state-of-the-art production line with 4 x 2,000L single-use bioreactors in Milford, MA, USA – State-of-the-art purification processes – Guaranteed product quality and purity in accordance with cGMP guidelines As a world-class solution provider, with over 50 years of experience, we ensure optimum time-to-clinic and time-to-market by accelerating timelines to create a competitive advantage for our clients. For seamless market approval, we consult and assist clients with regulatory queries, develop optimized strategies, and generate complete documentation for approval of clinical studies and market launch.

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Renaissance Lakewood

Renaissance is a US-based contract development and manufacturing organization (CDMO) for pharmaceutical and biotech companies. With over 20 years of experience in nasal sprays and sterile injectable dosage forms, we have an unparalleled track record of helping our clients from development to commercial launch. Core Capabilities: – Aseptic fill-finish development and manufacturing (vials) – Unit-dose and bi-dose nasal spray development and manufacturing – Preserved and Non-preserved multi-dose nasal spray development and manufacturing – Analytical development & testing services – Spray characterization development & testing services -Formulation development & optimization – DEA Schedule I-V products. From early-stage development through final production, Renaissance has the expertise and resources you need for success. Visit www.renpharm.com to learn more. | Renaissance is a US-based contract development and manufacturing organization (CDMO) for pharmaceutical and biotech companies. With over 20 years of experience in nasal sprays and sterile injectable dosage forms, we have an unparalleled track record of helping our clients from development through to commercial launch. Core Capabilities: – Aseptic fill-finish development and manufacturing (vials) – Unit-dose and bi-dose nasal spray development and manufacturing – Preserved and Non-preserved multi-dose nasal spray development and manufacturing – Analytical development & testing services – Spray characterization development & testing services – Formulation development & optimization – DEA Schedule I-V products From early-stage development through final production, Renaissance has the expertise and resources you need for success. Visit renpharm.com to learn more.

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Recipharm

Introducing ReciBioPharm, Recipharm’s biologics business combining the capabilities of recently acquired CDMOs Arranta Bio, GenIbet and Vibalogics. Our expanded biologics drug development and manufacturing services encompass technologies based on live viruses and viral vectors, live-microbial biopharmaceutical products, recombinant proteins, nucleic acid-based mRNA and plasmid DNA production. Established in 1995, Recipharm’s manufacturing, fill-finish, and delivery-device services canvass a wide variety of drug dosage forms and modalities. Recipharm is an industry leading CDMO with over 30 facilities and 9,000 employees globally – servicing companies that are developing small-molecules, biologics, and drug-device combinations. | Introducing ReciBioPharm, Recipharm’s biologics business combining the capabilities of acquired CDMOs Arranta Bio, GenIbet and Vibalogics. Our expanded biologics drug development and manufacturing services encompass technologies based on live viruses and viral vectors, live-microbial biopharmaceutical products, recombinant proteins, nucleic acid-based mRNA and plasmid DNA production. Established in 1995, Recipharm’s manufacturing, fill & finish, and delivery services encompass a wide variety of drug dosage forms and modalities. Recipharm is an industry leading CDMO with over 30 facilities and 7,400 employees globally – supporting companies that are developing small molecules and biologics. The company operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden, the UK and the US. | Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) employing over 5,000 employees. Recipharm provides manufacturing services of pharmaceuticals in various dosage forms, including, sterile fill & finish, oral solid dosage and biologics; clinical trial material development and manufacturing services; and, pharmaceutical product development. Its biologics segment, ReciBioPharm, works with customers to develop and commercialise advanced therapy medicinal products (ATMPs): pre-clinical to clinical and commercial development and manufacture for new biological modalities. The company operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden and the US. | Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) employing over 5,000 employees. Recipharm provides manufacturing services of pharmaceuticals in various dosage forms, including, sterile fill & finish, oral solid dosage and biologics; clinical trial material development and manufacturing services; and, pharmaceutical product development. Its Advanced Bio segment works with customers to develop and commercialise advanced therapy medicinal products (ATMPs): pre-clinical to clinical and commercial development and manufacture for new biological modalities. The company operates development and manufacturing facilities in France, Germany, India, Israel, Italy, Portugal, Spain, Sweden and the US.

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Quotient Sciences

Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we save precious time and money in getting drugs to patients. Everything we do for our customers is driven by an unswerving belief that ideas need to become solutions, molecules need to become cures, fast. Because humanity needs solutions, fast. | Quotient Sciences provides integrated CDMO and CRO services that cut through silos across the entire drug development pathway to save precious time and money getting drugs to patients. With facilities located in the US and the UK, we provide tailored services in areas such as drug product formulation development, clinical pharmacology including Phase I clinical trials, commercial drug product manufacturing, data sciences, and our industry-leading Translational Pharmaceutics® platform for drug development. | With trusted scientific insight brought to every program and 35+ years of ensuring quality & control throughout the development process, Quotient Sciences is a drug development & manufacturing accelerator helping clients bring molecules to cures, fast. Services for drug product span from early phase to late-stage and commercial, and our clinical pharmacology services are focused on early phase, with a full suite of Phase I studies from first-in-human (FIH), single and multiple ascending dose (SAD / MAD) to regulatory and exploratory clinical studies including human ADME, TQT, DDI, and bioavailability studies. We pioneered the integration of CRDMO services to create Translational Pharmaceutics®—a unique and disruptive platform that integrates drug product manufacturing & clinical testing for better clinical outcomes, reduced costs & timeline acceleration by up to 12 months.

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